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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 027 02 17 000
Date submitted: 2/9/2017
Manufacturer:Smith & Nephew
Device Type:OSTEORAPTOR SUTURE ANCHOR WITH ULTRABRAID SUTURES
Description:Sutures
Medical Device Identifier:Product Number: (Description; Lot)
1) 72201991 : ( OSTEORAPTOR 2.3 Suture Anchor W/ONE ULTRABRAID (#2) Suture; 50600657, 50560521, 50487785, 50494254, 50506297, 50476988, 50530461, 50597650, 50598959, 50537141, 50564182, 50595170, 50555978, 50511342, 50570333, 50542668, 50571777, 50487786, 50497603, 50488284, 50497277, 50486698, 50575504, 50571782, 50588643, 50554079, 50500339, 50496037, 50507463, 50595167, 50526004, 50595166, 50474895, 50598741, 50532061, 50571772, 50604177, 50498825, 50598958, 50592970)
2) 72202165 : ( OSTEORAPTOR 2.9 Suture Anchor W/ONE ULTRABRAID (#2) Suture; 50496068, 50558049, 50594103, 50479835, 50550566, 50479833, 50483677, 50579175, 50482234, 50519599, 50510232, 50485395, 50477593, 50514234, 50482885, 50497416)
Reason of Field Safety Corrective Action:The outer box label incorrectly states the suture color as blue; the provided suture is white. The inner label is correct.
Remedy Action:Actions for Hospital Representatives:
1. Please inspect your inventory and complete the attached Inventory Correction Certification Form.
2. If you have the affected products, please maintain awareness of this notice.
Athorized Representative/Importer/Distributor:
Report Source:NCMDR
Source Ref. Number:AACFD8248A2FF
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Smith & Nephew.pdf